Regulatory Affairs Manager

Our client is a leading global organization in Women’s Health with a strong focus on contraceptive and reproductive healthcare solutions. With state-of-the-art manufacturing facilities and in-house R&D expertise, the company has developed innovative medical devices and solutions that have empowered millions of women worldwide. The organization is certified under ISO 9001, ISO 14001, WHO GMP, CE, and ISO 13485 standards.

Job Description – Manager, Regulatory Affairs (RA)

Location: Daman

Experience: 12+ Years (relevant regulatory affairs experience)

Qualification: M.Pharm

Key Responsibilities

Develop and implement global regulatory strategies to ensure timely product approvals and market access across multiple health authorities (FDA, EMA, MHRA, TGA, Health Canada, etc.).

Provide regulatory intelligence and strategic advice to senior management on evolving regulations and their potential impact on business.

Collaborate with R&D, Quality, Manufacturing, and Marketing teams to align regulatory activities with overall business goals.

Prepare, compile, and submit Controlled Correspondence, Pre-submission Meeting Requests, and Scientific Advice for US, EU, Canada, and other global markets.

Evaluate pre-PIFs and provide regulatory submission requirements for US & EU, with extended submissions for Australia, Canada, and other regions.

Define and implement regulatory strategies to ensure business continuity and Day 1 launches in Europe, Canada, Australia, UK, China, and other key markets (Type IA/IB/II Supplements, Category 3 Notifications).

Act as a CMC expert for initial submissions and lifecycle management in global markets (US, EU, Canada, Australia, China, and emerging regions) across multiple dosage forms: OSDs, Ophthalmics, Complex Injectables, and Liposomal products.

Author and review CMC documentation (dossiers, technical files, deficiency responses), ensuring technical accuracy and compliance with agreed regulatory strategies.

Lead cross-functional teams for new product development, regulatory submissions, and post-approval lifecycle management.

Ensure ongoing compliance with international regulatory standards; manage audits and inspections by global authorities.

Manage and mentor the Regulatory Affairs team, ensuring compliance with applicable guidelines for pharmaceuticals and biologics (ANDA, NDA, DCP, CP, ANDS applications).

Conduct regulatory evaluations of change controls, deviations, OOS/OOT events, and other quality incidents to assess regulatory impact.

Utilize and oversee regulatory software systems such as LIMS, TrackWise, PharmaReady, Amplexor, etc.